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Product Quality Officer

Geneva

  • Organization: UNOPS - United Nations Office for Project Services
  • Location: Geneva
  • Grade: Mid level - IICA-2, International Individual Contractors Agreement
  • Occupational Groups:
    • Procurement
  • Closing Date: Closed

Background Information - UNOPS

UNOPS

UNOPS supports the successful implementation of its partners’ peacebuilding, humanitarian and development projects around the world. Our mission is to serve people in need by expanding the ability of the United Nations, governments and other partners to manage projects, infrastructure and procurement in a sustainable and efficient manner.

Working in some of the world’s most challenging environments, our vision is to advance sustainable implementation practices, always satisfying or surpassing our partners’ expectations.

With over 7,000 personnel spread across 80 countries, UNOPS offers its partners the logistical, technical and management knowledge they need, wherever they need it.

A flexible structure and global reach means that we can quickly respond to our partners' needs, while offering the benefits of economies of scale.

Stop TB Partnership

UNOPS hosts the Stop Tuberculosis Partnership Secretariat (STBP) as of 1 January 2015, in Geneva, Switzerland. The vision of the Stop TB Partnership is to realize the goal of elimination of Tuberculosis (TB) as a public health problem and, ultimately, to obtain a world free of TB by ensuring that every TB patient has access to effective diagnosis, treatment and cure; stopping transmission of TB; reducing the inequitable social and economic toll of TB; and developing and implementing new preventive, diagnostic and therapeutic tools and strategies. The Stop Partnership is uniquely positioned to support the development and further implementation by partners of the current and future Global Plan, acting as a coordinator and catalyst for the range of partners engaged in the fight against TB.

Founded in 2001, the Stop TB Partnership's mission is to serve every person who is vulnerable to TB and ensure that high-quality treatment is available to all who need it. Our partners include international and technical organizations, government programmes, research and funding agencies, foundations, NGOs, civil society and community groups and the private sector

As a key initiative of the STBP, the goal of the Global Drug Facility (GDF) is to facilitate world-wide, equitable access to TB medicines and diagnostics across both public and private sectors. This goal is achieved through management and coordination of market activities for the full portfolio of TB medicines and diagnostics, strategic procurement and innovative logistics solutions, technical assistance and capacity building for TB program in better pharmaceutical management practices, and accelerated uptake of new TB medicines, regimens, and diagnostics using the GDF “launch pad”.

The GDF procures all groups of medicines and key diagnostic tools that are currently recommended by WHO for diagnosis, prevention and treatment of drug susceptible and resistant forms of TB. When procuring through GDF, countries are ensured to receive quality-assured TB products in compliance with WHO Prequalification Program and Stringent National Medicines Regulatory Authorities or the Global Fund – ERP program.  

In addition, GDF applies a unique drug monitoring program coordinated with and performed by contracted Quality control agents which consists of the review of certificate of analysis for procured products, pre-shipment inspection of consignments, sampling and quality testing of products supplied to countries.

GDF’s Quality Assurance policy not only ensures supply of quality medicines, but it also leads to increased overall procurement efficiency and contributes indirectly to the reduction of delivery lead times.

Functional Responsibilities

The Stop TB Partnership is hiring a Product Quality Officer who will work under the supervision of the Product Quality Lead to ensure that TB medicines and diagnostics procured and supplied by GDF to countries are quality assured and of adequate standard.

The Product Quality Officer will be responsible of the following activities:

a)     S/he improves the GDF product quality and regulatory related tools, systems and processes:

-       Identify QA issues, challenges and risks, and propose innovative solutions and optimal risk-mitigation measures

-       Develop and maintain excel/access tool that tracks the availability of valid regulatory and quality documents for importation of TB medicines and diagnostics, as per the National Regulatory Authorities requirements

-       Create a dashboard for rapid tracking and review of product quality and regulatory documents

-       Maintain and improve the standardized excel/access tool for systematic review of product Certificate of Analysis (CoA) vs approved pharmacopeia monographs; provide brief analysis of the currently available results;

-       Enhance TB medicines and diagnostics quality complaints management and its recording and reporting tool.

-       Contribute to analytical work on the effectiveness and impact of GDF QA policy for TB medicines and diagnostics from a product and access perspective

-       Ensure availability of QA training, technical updates, and best practices sharing sessions

b)    S/he stands as GDF QA responsible person for diagnostics:

-       Review and update the GDF QA policy for diagnostics

-       Establish the GDF quality monitoring program for diagnostics

-       Manage and monitor the operationalization and implementation of the QA policy and quality monitoring program for diagnostics, including quality testing requirements, selection of quality control agents/laboratories

-       Monitor QA status progress for WHO recommended diagnostics

-       Act as the quality focal point for GDF diagnostic tenders

-       Act as focal point for managing diagnostic quality complaints

-       Work in close collaboration with partners, including normative agencies such as WHO and regulatory authorities, technical partners and manufacturers.

-       Work with partners toward harmonization of QA policy for diagnostics and approaches to respond to countries program needs for access to quality-assured diagnostics

c)     Assist with developing the GDF online TB products catalogue.

d)    Review and maintain up to date the GDF list of quality assurance and quality control (QA/QC) activities and achievements on the Stop TB /GDF webpage. e)    Perform other related responsibilities as assigned by GDF Product Quality Lead.

Monitoring and Project Controls

Quarterly reporting on activities and deliverables to GDF Product Quality Lead for performance monitoring.

Education

  • Advanced university degree (master's or equivalent) in pharmacy, medicine or public health. 

Experience

  • A minimum of 5 years of professional experience working in quality assurance for Health Products (in particular for pharmaceutical products and/or diagnostic products) including in quality control, at national and international level
  • Experience working in international organizations, such as UN agencies, donors or technical agencies, NGOs and/or private sector companies
  • Experience in developing partnerships with UN agencies, international NGOs and donors on QA issues
  • Experience in developing QA related policies, tools and guidance for diagnostics
  • Experience in Public Health/Procurement and Supply Chain Management (PSM) of Health Products
  • Experience in managing complex situations, issues at country, regional and international level
  • Experience in working in the TB environment, TB medicine or diagnostic management

Certifications

  • Quality assurance and quality control diploma, especially for diagnostics, is an asset.

Languages

  • English and French are the working languages of the United Nations Secretariat. For this post, fluency in English is required and good working knowledge of French preferably.
  • Working knowledge of other UN official languages is desirable.

Competencies

Develops and implements sustainable business strategies, thinks long term and externally in order to positively shape the organization. Anticipates and perceives the impact and implications of future decisions and activities on other parts of the organization.
Treats all individuals with respect; responds sensitively to differences and encourages others to do the same. Upholds organizational and ethical norms. Maintains high standards of trustworthiness. Role model for diversity and inclusion.
Acts as a positive role model contributing to the team spirit. Collaborates and supports the development of others. For people managers only: Acts as positive leadership role model, motivates, directs and inspires others to succeed, utilizing appropriate leadership styles.
Demonstrates understanding of the impact of own role on all partners and always puts the end beneficiary first. Builds and maintains strong external relationships and is a competent partner for others (if relevant to the role).
Efficiently establishes an appropriate course of action for self and/or others to accomplish a goal. Actions lead to total task accomplishment through concern for quality in all areas. Sees opportunities and takes the initiative to act on them. Understands that responsible use of resources maximizes our impact on our beneficiaries.
Open to change and flexible in a fast paced environment. Effectively adapts own approach to suit changing circumstances or requirements. Reflects on experiences and modifies own behavior. Performance is consistent, even under pressure. Always pursues continuous improvements.
Evaluates data and courses of action to reach logical, pragmatic decisions. Takes an unbiased, rational approach with calculated risks. Applies innovation and creativity to problem-solving.
Expresses ideas or facts in a clear, concise and open manner. Communication indicates a consideration for the feelings and needs of others. Actively listens and proactively shares knowledge. Handles conflict effectively, by overcoming differences of opinion and finding common ground.

Functional competencies

  • Understanding of QA matters in the pharmaceutical manufacturing context and for diagnostics
  • Understanding of WHO pre-qualification procedures of medicines and diagnostics and the assessment/ registration procedures followed by stringent regulatory authorities, knowledge or understanding of national regulatory requirements and processes in low and middle income countries
  • Understanding of the influence of national and global health policy issues (in particular those related to QA) on procurement and supply of pharmaceuticals and diagnostics
  • Knowledge of pharmaceutical procurement and supply chain good practices
  • Take the lead in solving complex issues.
  • Analytical thinking with ability to draw on complex data sources to provide strategic recommendations.
  • Adapt policy and guidance to the reality / context.
  • Excellent communication, planning and organizational skills, attention to detail, ability to multi-task, ability to work effectively under pressure and meet deadlines
  • Cultural sensitivity and integrity.

Additional Considerations

  • Please note that the closing date is midnight Copenhagen time
  • Applications received after the closing date will not be considered.
  • Only those candidates that are short-listed for interviews will be notified.
  • Qualified female candidates are strongly encouraged to apply.
  • For staff positions only, UNOPS reserves the right to appoint a candidate at a lower level than the advertised level of the post
  • The incumbent is responsible to abide by security policies, administrative instructions, plans and procedures of the UN Security Management System and that of UNOPS.  

It is the policy of UNOPS to conduct background checks on all potential recruits/interns. Recruitment/internship in UNOPS is contingent on the results of such checks.

This vacancy is now closed.
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